MAUDE Adverse Event Report: MSD DEGGENDORF MFG PEEK PREVAIL CERVICAL INTERBODY DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	4210664
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: cervical spondylosis, 5, 6, and 7 discs protruding from the neck procedure: anterior cervical decompression bone graft fusion and internal fixation level implanted: 2 (prosthesis) it was reported that, intra-op, the nitinol locking ring on the prosthesis was broken.The product came in contact with the patient.Fragment remained in the patient.The patient has not undergone revision surgery.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Additional information: x-ray image review result: post of x-rays for c5-6, c6-7 acdf show no obvious hardware failure.Implant date is (b)(6) 2018.There may be a discontinuity in one of the views on an ap x-ray.Fusion looks to be present.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PEEK PREVAIL CERVICAL INTERBODY DEVICE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 8455033
• Report Number: 1030489-2019-00326
• Device Sequence Number: 345158
• Product Code: ODP
• UDI-Device Identifier: 00613994502094
• UDI-Public: 00613994502094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2025
• Device Catalogue Number: 4210664
• Device Lot Number: 95DJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR